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Mission Glucose Reagent is intended for in vitro diagnostic use for the quantitative determination of glucose in serum, plasma, cerebrospinal fluid (CSF) and urine on Beckman Synchron CX® & CX® Delta Systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and pancreatic islet cell carcinoma.

Glucose concentration is determined by an oxygen rate method employing a Beckman Oxygen Electrode. Electronic circuits determine the rate of oxygen consumption, which is directly proportional to the concentration of glucose in the sample. Mission manufactures reagents intended to serve as direct replacements to like named products manufactured by Original Equipment Manufactures (OEM). All CX® & CX® Delta Systems that measure glucose utilize the same measurement method and reagent. The reagent is intended for use on equivalent OEM Instruments. Mission uses a similar composition, description and packaging as that used by the OEM in its products.

Here's an analysis of the provided text, outlining the acceptance criteria and the study used to demonstrate the device meets these criteria.

Acceptance Criteria and Device Performance for Mission Diagnostic Glucose Reagent

This medical device is an in-vitro diagnostic reagent intended for the quantitative determination of glucose in various biological samples (serum, plasma, CSF, and urine) on Beckman Synchron CX® & CX® Delta Systems. The goal of the 510(k) submission is to demonstrate substantial equivalence to an existing predicate device (Beckman PN 443355 Glucose Reagent). Therefore, the acceptance criteria are implicitly tied to demonstrating comparable performance to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a glucose reagent intended to be substantially equivalent to an existing one, the "acceptance criteria" are not explicitly stated as strict pass/fail thresholds in the provided document. Instead, the study aims to show that the Mission Glucose Reagent performs similarly to the predicate Beckman reagent. The reported performance metrics are designed to demonstrate this similarity across various aspects.

2. Sample Size Used for the Test Set and Data Provenance

• Precision Study:
  • Sample Size: 80 measurements for each of the 6 control levels (CSF Control 1 & 2, Serum Control 1 & 2, Urine Control 1 & 2). This involved 20 days, 2 runs per day, 2 observations per run (20 * 2 * 2 = 80).
  • Data Provenance: Not explicitly stated, but typically these samples are laboratory-prepared control materials. The study was conducted on an "instrument operated according to the manufacturers instructions," implying in a controlled lab environment. This would be considered prospective data collection.
• Method Comparison Study:
  • Serum: n = 50 serum samples.
  • Urine: n = 57 urine samples.
  • CSF: n = 36 CSF samples.
  • Data Provenance: Samples were "spiked or diluted." This suggests a combination of patient samples and artificially prepared samples. The origin (country/institution) is not specified. It is likely prospective data collection, as samples were "run in triplicate and tested with each reagent."
• Recovery to Expected Values Study:
  • Sample Size: Numbers for specific dilutions/spikes are not provided, but generally involved "pooled serum," "urine control 1 & 2," and "CSF control 1 & 2" with various dilutions.
  • Data Provenance: Laboratory-prepared spiked and diluted control materials and pooled samples. This is prospective data.
• Functional Sensitivity Study:
  • Sample Size: 20 measurements (4 samples per run over 5 calibrated runs) for each of the 5 dilution levels (43, 14, 9, 2, 0 mg/dL expected values).
  • Data Provenance: Laboratory-prepared dilutions of serum samples. This is prospective data.

3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts

This type of device (glucose reagent for in-vitro diagnostics) does not typically involve human experts for establishing ground truth as understood in imaging or clinical decision support AI. The "ground truth" here is the actual concentration of glucose in a sample, determined by highly accurate reference methods or by the predicate device itself.

• Ground Truth Establishment:

  • For Method Comparison, the "ground truth" for comparison is the result obtained from the predicate Beckman Glucose Reagent.
  • For Recovery to Expected Values, the "ground truth" is the gravimetrically determined or calculated expected concentration of glucose in the spiked/diluted samples.
  • For Functional Sensitivity, the "ground truth" is the calculated expected value of the diluted serum samples.

• Number and Qualifications of Experts: Not applicable in the context of this device and study. The accuracy relies on the performance of the analytical instrument and comparison to a well-established predicate or gravimetric preparation.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in studies where human expert interpretations are subject to disagreement. This is not relevant for an in-vitro diagnostic reagent study where quantitative measurements are compared.

• Adjudication Method: Not applicable. Measurements are quantitative, and differences are analyzed statistically.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was a MRMC study done? No. This type of study is for evaluating human reader performance, often with or without AI assistance, especially in imaging. It is not relevant for an in-vitro diagnostic reagent.
• Effect size of human readers improve with AI vs without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

• Was a standalone study done? Yes, in a sense. The studies described (Precision, Method Comparison, Recovery, Functional Sensitivity) evaluate the performance of the Mission Glucose Reagent (the "algorithm" or device under test) independently of human interpretation bias. Its performance is measured directly against the predicate or expected values. The instrument (Beckman Synchron CX® & CX® Delta Systems) executes the reagent's chemistry, and the results are read directly.

7. Type of Ground Truth Used

• Method Comparison: The predicate device's measurement (Beckman Glucose Reagent) was used as the comparative "ground truth."
• Recovery to Expected Values: Gravimetrically determined or calculated expected concentrations in spiked/diluted samples.
• Functional Sensitivity: Calculated expected values based on dilutions of known concentration.
• Precision: No external ground truth is used; it assesses the reproducibility of the device's own measurements.

8. Sample Size for the Training Set

The concept of a "training set" is usually associated with machine learning or AI models. This device is a chemical reagent, not an AI algorithm. Therefore, there is no "training set" in the conventional sense. The development of the reagent would involve formulation and optimization experiments, but these are distinct from a machine learning training set.

• Sample Size for Training Set: Not applicable.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for this chemical reagent, this question is not applicable.

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The Glucose Reagent is to be used to aid in the diagnosis of diabetes mellitus and other associated with glucose abnormalities.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a Glucose Reagent. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain the specific information required to answer your questions about acceptance criteria and the study that proves the device meets those criteria.

The details you requested, such as a table of acceptance criteria, device performance, sample size for test and training sets, data provenance, expert qualifications, adjudication methods, MRMC study results, standalone performance, and ground truth establishment, are typically found in the 510(k) submission summary itself, or in supporting clinical study reports, not in the FDA's clearance letter.

The clearance letter primarily confirms that the FDA has reviewed the submission and determined that the device is substantially equivalent to a predicate device for the stated indications for use. It outlines the regulatory class, product code, and general controls provisions but does not delve into the detailed performance data that would support the acceptance criteria.

Therefore,Based on the provided FDA clearance letter (K970664 for Glucose Reagent), the following answers can be given:

1. A table of acceptance criteria and the reported device performance:

   • This information is not available in the provided document. The document is an FDA clearance letter confirming substantial equivalence, not a summary of the performance study or acceptance criteria.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This information is not available in the provided document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • This information is not available in the provided document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • This information is not available in the provided document.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • This information is not available in the provided document. Given that the device is a "Glucose Reagent" (an in-vitro diagnostic device, likely a chemical assay), an MRMC study involving human readers assisting with AI is not applicable to this type of medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • This information is not available in the provided document. For a Glucose Reagent, the "standalone" performance would refer to the reagent's analytical performance (e.g., accuracy, precision) in a lab setting, which would have been part of the substantial equivalence demonstration, but the details are not in this letter.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • This information is not available in the provided document. For a Glucose Reagent, the "ground truth" would typically come from reference methods for glucose measurement.

8. The sample size for the training set:

   • This information is not available in the provided document.

9. How the ground truth for the training set was established:

   • This information is not available in the provided document.

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